Now clinicians in U.S. at last have a device based treatment to help decrease the symptoms of opioid withdrawal. FDA allowed a new indication to Innovative Health Solutions for its NSS-2 Bridge nerve stimulator. The new indication was audited under FDA’s once more pathway.
FDA Commissioner Scott Gottlieb, MD., said, “There are three approved drugs for helping treat opioid addiction. While we keep on pursuing better prescriptions for the treatments of opioid utilized is order, we additionally need to look to devices that can aid this treatment.”
FDA supports the advancement of both drug and device-based treatments that can be utilized to address opioid addiction or dependence, and in addition new, non-addictive treatments for pain that can fill in as contrasting options to opioids, said by Gottlieb.
The NSS-2 Bridge device is a little electrical nerve stimulator put behind the patient’s ear. It contains a battery-powered chip that radiates electrical pulses to stimulate branches of certain cranial nerves. Such stimulations may give alleviation from opioid withdrawal symptoms, the agency noted. The device is set behind the ear with microneedle exhibits that percutaneously embed in and around the ear.
Patients can utilize the device for up to five days during the acute physical withdrawal stage. The symptoms of opioid withdrawal cause acute physical withdrawal including insomnia, agitation, joint pain, sweating, and gastrointestinal upset.To curb opioid use, NSS-2 Bridge is one of several emerging devices that could help.
FDA checked on information from a single-arm study of 73 patients experiencing opioid physical withdrawal. The examination assessed patients’ clinical opiate withdrawal scale (COWS) score, which is a clinical evaluation led by a healthcare professional that measures opioid withdrawal symptoms. clinical opiate withdrawal scale (COWS)scores from 0 to more than 36, the higher the number, the more serious the manifestations are to a patient.
Preceding utilizing the device, the normal COWS score for all patients was 20.1. Study comes about demonstrated that all patients had a decrease in COWS of no less than 31% within 30 minutes of utilizing the gadget. By and large, 64 of the 73 patients (88%) changed to medication-assisted treatment following five days utilizing the device, along with any medications required for persevering symptoms, for example, nausea and vomiting.
In 2014, FDA cleared the EAD (electro auricular device, now called Bridge Neurostimulation System) for use in acupuncture. FDA’s granting of the present demand for the NSS-2 Bridge extends the utilization of the device as a aid to decrease the symptoms of opioid withdrawal. It is available just by prescription. The device is contraindicated in patients with hemophilia, patients with cardiovascular pacemakers or those determined to have psoriasis vulgaris.
Brian Carrico, leader of IHS said, “Our vision is for each individual in withdrawal, getting ready for withdrawal, or experiencing post-acute withdrawal symptoms (PAWS), to approach this innovation. Essentially decreasing withdrawal symptoms diminishes the dependency on opioids, takes into consideration less demanding change to medically assisted treatment (MAT) and at last fills in as another device to battle the opioid scourge confronting our nation.”
Withdrawal symptoms from opioids can show rapidly and include nausea, vomiting, anxiety, abdominal pain and restlessness. IHS noted, frequently these symptoms are so agonizing and overpowering, individuals swing back to opioids after just a couple of hours. Carrico said, “The innovation gives those suffering from opioid habit a less demanding progress to all types of MAT. The device helps take away the fear of withdrawal and prompts a considerably higher achievement rate.”